APPLICATION OF THE SIX-SIGMA METHOD IN CONTROLLING AND IMPROVING THE QUALITY OF SEVERAL COAGULATION INDICATORS ON THE STAGO STA R MAX MACHINE AT HUE UNIVERSITY OF MEDICINE AND PHARMACY HOSPITAL
Main Article Content
Abstract
Research Problem: Laboratory test result errors can occur before, during, and after testing. Implementing proper evaluation using internal and external quality control methods helps minimize these errors.
Objectives: 1. To calculate the Six Sigma values of laboratory parameters: PT, aPTT, Fibrinogen by using the STAGO STA R MAX analyzer based on the laboratory’s internal and external quality control results. 2. To evaluate the performance of the analysis process and propose corrective measures for parameters with low Six Sigma results.
Research Design: Cross-sectional descriptive study.
Location and Time: Department of Hematology and Blood Transfusion - Hue University of Medicine and Pharmacy Hospital, from January 2025 to December 2025.
Materials: Six Sigma values were determined through the variance (CV%) obtained from internal quality control results, bias obtained from external quality control results, and the total allowable error (TEa) referenced from CLIA. From there, the Six Sigma value was calculated.
Results: Only Fibrinogen at level 1 achieved a Six Sigma value greater than 3, while the remaining test indices fell within the range of 2 to 3.
Conclusion: The Six Sigma method could be applied to evaluate the performance of basic coagulation function tests based on the results of internal and external quality control by the laboratory, thereby helping to better control test quality.
Keywords
CV, Bias, TEa, Six Sigma, CLIA
Article Details
References
2. Kumar BV, Mohan T. Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory. J Lab Physicians. 2018;10(2):194–199.
3. Erdogan-Doventas Y, Ozdemir-Anayurt E, Erdogan H, et al. Performance Evaluation of a Coagulation Laboratory Using Sigma Metrics and Quality Goal Index. Clin Lab. 2024;70(12):2254–2257.
4. Aksit M, Colak A, Basok BI, et al. Evaluation of analytical quality of coagulation parameters by sigmametric methodology. Int J Med Biochem. 2023;6(2):84–89.
5. Nagler M, Bachmann LM, Alberio L, et al. Variability between laboratories performing coagulation tests with identical platforms: a nationwide evaluation study. Thromb J. 2013;11(1):6.
6. Cavusoglu C. From kit inserts to daily practice: Six sigma and maximum allowable uncertainty in coagulation analysis. Medicine (Baltimore). 2025;104(40):e44978.
7. Sener A, Ucar F, Sehit C, et al. Evaluation of analytical phase performance of coagulation parameters by sigmametric methodology. Int J Med Biochem. 2024;7(3):168–173.